A Pilot Study to Evaluate the Therapeutic Efficacy of Intra-Lesional Immunotherapy in Patients Aged 10-60 Years With Recalcitrant Tinea Cruris and Corporis

NCT07312604 | Recruiting

• 1 other identifier: R.25.11.3446
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot study will test intra-lesional immunotherapy (MMR vaccine) injections as a treatment for recalcitrant tinea cruris and corporis in patients aged 10-60 years who have not improved with standard antifungal treatments. \*Eligibility: Participants must have recalcitrant tinea, defined as:

• Rapid progression or large areas of skin affected,
• Infection in multiple family members, especially females and children
• Rapid relapse after prior treatment
• Suspected resistant T. indotineae (based on travel history or contact with affected individuals from high-prevalence regions)
• Failure of at least 2 courses of systemic antifungal therapy in the past 3 months Treatment: Patients will receive intra-lesional MMR vaccine injections into the active borders of affected lesions every 2 weeks for up to 6 weeks. If partial improvement occurs but complete clearance is not achieved, the course may be repeated for another 6 weeks. Pulse itraconazole will be given during the first 2 weeks. Monitoring: At each study visit, clinicians will assess the extent of affected skin and monitor symptoms particularly itching. Safety will be closely observed, including injection-site reactions, fever, initial flare of lesions, and any rare serious allergic reactions. Goal: To evaluate the safety and effectiveness of intra-lesional MMR immunotherapy for patients with tinea that has been difficult to treat.

Conditions

Tinea Corporis; Tinea Cruris

Keywords

Tinea Cruris; Tinea Corporis; Recalcitrant Dermatophytosis; Intra-Lesional Immunotherapy; Pilot Clinical Study; Dermatophyte Treatment

Outcome Measures

Primary Outcomes (1)

• Percent reduction in affected body surface area (BSA) from baseline

  The primary efficacy endpoint is the percent reduction in the total body surface area affected by recalcitrant tinea (cruris and/or corporis), assessed by clinical examination at each study visit. This measure evaluates the improvement in lesion extent and treatment response over time.

  Assessed at each study visit (every 2 weeks) up to 6 weeks, with extension up to 12 weeks if improvement is notice after initial 6 weeks, but complete resolution isn't achieved.

Secondary Outcomes (1)

• Safety and Tolerability: Incidence and severity of treatment-emergent adverse events

  Monitored continuously throughout the initial 6-week treatment period, with continued observation up to 12 weeks if a second course is administered.

Study Arms (1)

Intra-Lesional Immunotherapy

EXPERIMENTAL

All participants with recalcitrant tinea cruris and/or tinea corporis will receive intra-lesional immunotherapy. There is no comparator or placebo group. Male and female participants are included in the same arm and will be analyzed as subgroups.Intra-Lesional Immunotherapy

Biological: Intra-Lesional MMR Immunotherapy

Interventions

Intra-Lesional MMR Immunotherapy BIOLOGICAL

Participants will receive intra-lesional immunotherapy using the measles-mumps-rubella (MMR) vaccine. The vaccine will be injected into the active borders of affected lesions every 2 weeks for a total duration of 6 weeks. Clinical assessment of lesion extent and symptoms, particularly pruritus, will be performed at baseline and at each visit. If partial clinical improvement is observed after the initial 6 weeks but complete resolution is not achieved, the treatment course may be extended for an additional 6 weeks, with a maximum of six intra-lesional injection sessions.

Also known as: MMR Vaccine, Measles-Mumps-Rubella Vaccine, Priorix®

Intra-Lesional Immunotherapy

Eligibility Criteria

• Age: 10 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age between 10 - 60 years.
• Evidence of recalcitrant tinea e.g. (rapid progression \& large areas affected of the body, affection of more than one family members especially females \& children, rapid relapse after treatment, suspicion of resistant T. indotineae strain by history of traveling abroad \& contact with Indians or contact with a case coming from travel \& with contact to Indians.
• Patients failed at least 2 courses of systemic antifungal therapy in the last 3 months.
• Safe contraception during the study (for females in the childbearing period).

You may not qualify if:

• Pregnant or lactating women, as well as women of childbearing potential not using an effective method of contraception.
• Age \<10 years or \> 60 years.
• Immunocompromised patients e.g. (uncontrolled DM or HIV patients).
• Naïve patients without previous systemic antifungal treatment.
• Unreliable patients.

Sponsors & Collaborators

• Abeer Mohamed Abdelaziz Elkholy: lead
• Mansoura University Hospital: collaborator

Study Sites (1)

Mansoura University Hospital

Al Mansurah, Dakahlia Governorate, 35511, Egypt

RECRUITING

MeSH Terms

Conditions

Tinea; Tinea Cruris

Interventions

Measles-Mumps-Rubella Vaccine

Condition Hierarchy (Ancestors)

Dermatomycoses; Mycoses; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases; Intertrigo; Dermatitis; Skin Diseases, Eczematous

Intervention Hierarchy (Ancestors)

Vaccines, Combined; Vaccines; Biological Products; Complex Mixtures; Measles Vaccine; Viral Vaccines; Mumps Vaccine; Rubella Vaccine

Central Study Contacts

Abeer Mohamed Elkholy, MD degree of Dermatology

CONTACT

+201006210646; abeerkholy@hotmail.com

Nora Mohamed Abdelrazik, MD degree of Dermatology

CONTACT

+201060291029; noraeldarawany@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Dermatology, Faculty of Medicine, Mansoura University

Study Record Dates

• First Submitted: December 17, 2025
• First Posted: December 31, 2025
• Study Start: December 9, 2025
• Primary Completion: March 9, 2026
• Study Completion: March 9, 2026
• Last Updated: December 31, 2025

Record last verified: 2025-12

Locations

EG (1)